BEUDAMED
    FDA Enforcement Class I Terminated

    Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.

    Recall: Z-0765-2019 · Reported February 6, 2019

    Enforcement

    Recall Number
    Z-0765-2019
    Event ID
    81878
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Edwards Lifesciences, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 6, 2019
    Initiation Date
    December 21, 2018
    Classification Date
    January 31, 2019
    Termination Date
    November 2, 2023
    Address
    1 Edwards Way, N/A, Irvine, CA, 92614-5688, United States

    Description

    Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.

    Reason

    These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms.

    Code Info

    Lot Numbers: 61176367, 61176370

    Distribution

    Worldwide Distribution

    Quantity

    459 units